Kornimate/medical-research-clean huggingface dataset:
a clinical study to investigate collagen matrix 10808 for soft tissue volume augmentation around single implants

Conditions: Tooth Loss; Soft Tissue Deficiency

Summary: the objective of this study is to investigate the safety and the function of the collagen matrix 10808 in humans and to compare it versus the standard therapy, the transplantation of the autologous connective tissue graft. the collagen matrix was developed for soft tissue augmentation. it is a three dimensional porous matrix and consists mainly of collagen i and iii. study patients must have a single tooth gap with insufficient soft tissue volume after implant placement. therefore a soft tissue augmentation will be necessary.

the primary objective of this study is to assess the effectiveness of soft tissue volume augmentation procedures using the autogenous soft tissue graft or the collagen matrix 10808 to gain mucosal thickness. second the safety of the two procedures will be investigated.

Eligibility criteria:
inclusion criteria: 1. implant placement at least 6 weeks and maximum 6 months prior enrolment 2. necessity of soft tissue augmentation in single tooth gap 3. 2 teeth adjacent to each side of the defect have a mean bop (bleeding of probing) of \< 30% 4. basic periodontal examination (bpe \<2) 5. 18 years or older 6. ability to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures 7. ability to fully understand the nature of the proposed surgery and ability to sign the informed consent form exclusion criteria: 1. heavy smoker (\> 10 cigarettes per day) 2. probing depth greater than 4 mm 3. insulin dependent diabetes 4. general contraindications for dental and/or surgical treatment 5. history of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years 6. women of child bearing age, not using a standard accepted method of birth control 7. pregnancy or breast feeding 8. previous and concurrent medication affecting mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs) 9. disease affecting connective tissue metabolism (e.g. collagenases). 10. allergy to collagen 11. participation in a clinical trial within the last six months
atherectomy by laser ablation with turbo-elite

Conditions: Peripheral Arterial Disease; Peripheral Vascular Disease

Summary: the primary objective for this study is to prove the safety and effectiveness of the spectranetics turbo-elite catheter in atherectomy treatment for infrainguinal arteries with catheter to vessel sizing of at least 50%.


Eligibility criteria:
inclusion criteria: * pad with rutherford class 1-4 * patient is able to walk unassisted or with non-motorized assistive devices. * documented pad by abi \<0.9 or previous intervention with reoccurrence of symptoms * documented stenosis by duplex ≥50% exclusion criteria: * patient is pregnant or breast feeding. * evidence of acute limb ischemia within 7 days prior to procedure. * cva \< 60 days prior to procedure. * mi \< 60 days prior to procedure. * known contraindication to aspirin, antiplatelet/anti-coagulant therapies required for procedure/follow up. * known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure. * uncontrolled hypercoagulability or history of hit or hitts syndrome. * serum creatinine ≥ 2.5 mg/dl (unless dialysis-dependent) within one day prior to procedure. * patient is simultaneously participating in another investigational drug or device study that will interfere with the 30 day safety endpoint. * previously identified severe calcium in the vessel.
clinical outcomes following treatment with systane® balance

Conditions: Dry Eye

Summary: the purpose of this study is to evaluate the clinical effectiveness of systane® balance compared to refresh optive® advanced in subjects with lipid-deficient dry eye.


Eligibility criteria:
inclusion criteria: * willing and able to attend all study visits; * must sign an informed consent form; * best-corrected visual acuity (bcva) of 55 letters or better in each eye as assessed using an early treatment diabetic retinopathy study (etdrs) chart; * willing to take study products as directed for entire study; * other protocol-specified inclusion criteria may apply. exclusion criteria: * women of childbearing potential who are pregnant, plan to become pregnant during the study, breast feeding, or not using adequate birth control methods; * contact lens use within 30 days prior to screening visit, or unwilling to avoid contact lens use during the course of the study; * use of medication excluded by the protocol; * diseases, illnesses, infections, or ocular abnormalities excluded by the protocol; * ocular surgeries or procedures excluded by the protocol; * other protocol-specified exclusion criteria may apply.
the role of r-alpha lipoic acid in the treatment of atherosclerotic vascular disease

Conditions: Atherosclerosis

Summary: the purpose of this study is to see if a dietary supplement, r-alpha lipoic acid, is able to reduce risk factors in people with documented heart disease and increased levels of inflammation.


Eligibility criteria:
inclusion criteria: * documented congestive heart disease (chd)(defined as at least one significant coronary stenosis \> 50% on angiography, or history of documented myocardial infarction) * not diagnosed with unstable angina, uncontrolled hypertension, heart failure, recent myocardial infarction (within last six months) * not taking insulin or oral hypoglycemic agents, anti-inflammatory drugs other than aspirin, or hormone replacement therapy * on stable doses for four weeks prior to entry of lipid-lowering therapy (statins), aspirin, and angiotensin-converting enzyme inhibitors or other blood pressure medications. p * no tobacco use within 3 months of the study * no laboratory evidence of renal, hepatic, or hematological abnormalities * not currently taking vitamin or antioxidant supplements, including r-alpha lipoic acid, except standard multivitamin/mineral supplements containing not more than the daily value (dv) of the vitamins and minerals; * elevated levels of urinary and plasma f2-isoprostanes * elevated plasma levels of hs-crp

Keywords: atherosclerosis lipoic acid thioctic acid triglycerides overweight obesity oxidative stress inflammation
change in breathing pattern on non-invasive ventilation of copd patients under home mechanical ventilation

Conditions: Copd; COPD Exacerbation

Summary: acute exacerbation of copd (aecopd) worsen prognosis and quality of life of copd patients. telemonitoring could be a useful tool for early identification of aecopd. parameters that have to be monitored are not well defined. patients with severe copd may use home non-invasive ventilation (niv). niv have built-in software which are recording the breathing pattern of patients when used. the aim of this study is to identify ventilation parameters that are modified at the early stage of an aecopd.


Eligibility criteria:
inclusion criteria: * diagnosed copd according to gold guidelines * established on home non invasive ventilation for more than 2 weeks exclusion criteria: * none

Keywords: copd non invasive ventilation niv acute exacerbation copd aecopd telemonitoring
act-128800 in psoriasis

Conditions: Plaque Psoriasis

Summary: this study will assess the efficacy, safety, and tolerability of act-128800 in subjects with moderate to severe plaque psoriasis.


Eligibility criteria:
inclusion criteria: * adult males and females with moderate to severe plaque psoriasis who require systemic treatment and for whom participation in a placebo-controlled study of an investigational drug is justified. exclusion criteria: * patients with other forms of psoriasis and patients who are currently treated for autoimmune disorders other than psoriasis. * systemic or topical treatments for psoriasis other than emollients. * ongoing bacterial, viral or fungal infections. * history or presence of malignancy. * additional inclusion and exclusion criteria apply with respect to medical conditions and concomitant treatments which could affect patients' risk from participating in the study.
rn624 in adult patients with chronic low back pain

Conditions: Low Back Pain

Summary: the primary objective of this study is to evaluate the analgesic efficacy of rn624 compared with placebo and compared with naproxen in the treatment of adult patients with chronic low back pain.


Eligibility criteria:
inclusion criteria: * male or female of any race, \>18 years of age and have bmi ≤39 kg/m2 * present with duration of chronic low back pain of ≥3 months requiring regular use of analgesic medication (\>4 days per week for the past month) * primary location of low back pain is between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation into the posterior thigh, classified as category 1 or 2 according to the classification of the quebec task force in spinal disorders * must have a score of ≥4 for low back pain intensity (nrs) while on current treatment at screening, and completes at least 4 daily pain diaries during the 5 days prior to randomization, with an average low back pain intensity (nrs) score of ≥4 exclusion criteria: * back pain due to visceral disorder (i.e. endometriosis) or back pain due to recent major trauma (i.e. vertebral fracture, post-traumatic spondylolisthesis) * history of lumbosacral radiculopathy, spinal stenosis associated with neurological impairment, or neurogenic claudication * osteoporotic compression fracture within the last 6 months * known history of: rheumatoid arthritis; seronegative spondyloarthropathy (i.e., ankylosing spondylitis, psoriatic arthritis, reactive arthritis, inflammatory bowel disease-related arthropathy); paget's disease of spine, pelvis or femur; fibromyalgia; tumors or infections of the spinal cord * patients receiving acetaminophen only to manage their chronic low back pain * any uncontrolled or untreated chronic disease
gcssg-spnx: trial to evaluate splenectomy in total gastrectomy for proximal gastric carcinoma: jcog0110

Conditions: Gastric Neoplasm

Summary: the purpose of this study is to evaluate the role of splenectomy in potentially curative total gastrectomy for proximal gastric carcinoma in terms of survival benefit and post-operative morbidity.

european clinical trials of gastrectomy showed that splenectomy is an important risk factor for post-operative morbidity and mortality. retrospective comparisons suggested that splenectomy is associated with poor long term survival. however, japanese studies revealed that 20 - 30 % of patients with non-early carcinoma in the proximal stomach have nodal metastasis in the splenic hilum and therefore, pancreas-preserving splenectomy is part of the standard operation in specialized centers where splenectomy is not considered a risk factor for operative mortality. there have been no prospective randomized trials to evaluate the survival benefit of splenectomy in total gastrectomy for proximal gastric cancer. comparison: total gastrectomy with pancreas-preserving splenectomy versus total gastrectomy without splenectomy

Eligibility criteria:
inclusion criteria: preoperatively * histologically proven adenocarcinoma * t2 or deeper lesion in the upper third of the stomach without involvement of the greater curvature or esophageal invasion, irrespective of the primary tumor location or existence of multiple foci * no distant metastasis, not linitis plastica ('borrmann 4'), not stump carcinoma, no prior treatment for 364 randomized trial for splenectomy gastric cancer * sufficient organ function * written informed consent. intra-operatively * t2/t3/t4 and n0/n1/n2, no tumor on the greater curvature, no direct invasion of the pancreas or spleen, negative peritoneal lavage cytology * no apparent nodal metastasis in the splenic hilum or along the splenic artery exclusion criteria: * liver cirrhosis or portal hypertension * idiopathic thrombocytopenic purpura * severe pulmonary dysfunction * synchronous or metachronous (within 5 years) malignancy.

Keywords: gastric neoplasm gastrectomy splenectomy randomized trial t2, t3 and t4 carcinoma in the proximal third of the stomach
proximal junctional kyphosis following long instrumented spinal fusion: the effect of implant selection

Conditions: Kyphosis

Summary: the treatment of adult deformity has improved with the development and use of modern segmental instrumentation, including posterior instrumentation. however, the incidence of proximal junctional kyphosis (pjk) caused by the accelerated degeneration of the joint capsules and smaller articular processes in the proximal junctional region has also been noted. one potential way of decreasing pjk is to decrease the structural rigidity of the construct at the top thereby providing a transition to the non-instrumented spine and allowing for less facet capsule and muscle disruption.

while a possible solution to pjk is to reduce structural rigidity at the top of the construct, there is a need to investigate it. in the proposed study, the investigators will compare the rate of proximal junctional kyphosis in patients treated with a stainless steel rod (revere stabilization system) versus those treated with transition stabilization system. patient outcome measures (scoliosis research society (srs-22), sf12 and odi) and radiographic measurements (including lumbar lordosis (l1-s1), adjacent segment kyphosis, thoracolumbar kyphosis (t10-l2), sagittal balance, sacral slope, and pelvic incidence) will be analyzed.

Eligibility criteria:
inclusion criteria: * adult patients with degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudoarthrosis) requiring treatment with an instrumented posterior fusion from the thoracolumbar junction (t10-l1) to the sacrum * at least 18 years of age and maximum 70 years of age * ability to provide informed consent for study participation and patients to return for all follow-up visits exclusion criteria: * presence of systemic or localized infection * previous fusion attempt at the involved level(s) * more than three previous open, posterior, lumbar spinal surgical procedures at the involved level(s) * trauma at the levels to be fused * previous documentation of osteopenia or osteomalacia * diagnosis of a condition or requires postoperative medication(s), which may interfere with bony/soft tissue healing * presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, hiv, long term use of steroids, etc.) * immunosuppressive disorder * pregnancy * history of alcohol and/or drug abuse * any known allergy to a metal alloy * mentally incompetent or prisoner * currently a participant in another study * preoperative structural deformity in the thoracic spine (kyphosis \>60 degrees, coronal curve \>40 degrees) * circumferential fusion above l1

Keywords: rigid rods less rigid rods prevent kyphosis long constructs
preventing overweight in usaf personnel: minimal contact program

Conditions: Overweight; Obesity

Summary: the prevalence of overweight in the united states air force (usaf) is about 22%. the objective of this study is to compare the effectiveness of a minimal contact behavioral therapy plus usual care group(mcbt+uc) using a controlled experimental comparison of usual care(uc). subjects are usaf personnel who are 5lbs below their maximum allowable weight (maw) and heavier. the primary hypothesis is that: mcbt+uc will have significant weight loss as compared to uc.

the objective of this study is to compare the relative effectiveness of two approaches to weight management, using a controlled comparison experiment. the two approaches are: minimal contact behavior therapy plus usual care (mcbt+uc) which includes an orientation meeting, provision of a self-help book, use of an interactive weight management web site for 6 months, and 2 brief motivational interviewing telephone follow-ups, plus usual care;and usual care (uc) which includes and orientation meeting and usual care (consisting of required usaf annual physical and fitness exam, participation in any mandatory weight loss or fitness programs, and the requirement to stay below a maximum allowable weight \[maw\], with penalties or separation as potential contingencies for failure to remain below maw). the primary outcome is weight loss.additional outcomes include body mass index, percent body fat, and waist circumference.

Eligibility criteria:
inclusion criteria: * within 5 pounds below or equal to their maw or above maw according to usaf weight and height tables * access to personal computer with internet access * plan to remain in the local area for one year * male or female between the ages 18-55 years exclusion criteria: * pregnant, planning to become pregnant or becomes pregnant * weight loss of more than 10 pounds in the past 3 months * no prescription or nonprescription weight-loss medication for at least 6 months prior to screening * on any medical profile. specific exclusion includes history of myocardial infarction, stroke, or cancer in the past 5 years, diabetes, angina, and orthopedic or joint problems that would prohibit exercise.

Keywords: prevention of overweight prevention of obesity treatment of overweight treatment of obesity
surgery for mesothelioma after radiation therapy "smart" for resectable malignant pleural mesothelioma

Conditions: Mesothelioma; Solitary Fibrous Tumor of the Pleura

Summary: the purpose of this study is to determine whether radiation therapy decreases tumor size and tumor spread. the investigators will consent subjects that have been diagnosed with mesothelioma and will undergo radiation therapy followed by surgical resection as their standard of care. the investigators will collect data from past and future medical records as well as data regarding their health status for their lifetime by reviewing life status, treatment status and ct scans.


Eligibility criteria:
inclusion criteria: * subject provides informed consent * subject is \>18 years of age * subject is deemed competent for making medical decisions * subject is scheduled to undergo radiation followed by extrapleural pneumonectomy. * subject is a surgical candidate * a negative pregnancy test is required in women of child-bearing potential, as standard of care. exclusion criteria: * subject is \<18 years old.
combination of corticotherapy and intensive insulin therapy for septic shock

Conditions: Septic Shock

Summary: this study will compare, in adults with septic shock, the safety and efficacy of a combination of moderate doses of corticosteroids and intensive insulin therapy to that of moderate doses of corticosteroids. in addition, this study will compare the efficacy and safety of hydrocortisone alone versus hydrocortisone plus fludrocortisone

objectives: comparison, in patients with septic shock, of efficacy and safety of the combination of moderate doses of corticosteroids and intensive insulin therapy to that of moderate doses of corticosteroids; and of efficacy and safety of hydrocortisone alone versus hydrocortisone plus fludrocortisone methods study design : this is a multicenter, prospective, randomised trial on parallel groups study treatments : experimental arm a: a1=50 mg iv every 6 hours of hydrocortisone (hemisuccinate), 50µg through the nasogastric tube of 9 alpha fludrocortisone, for 7 days and strict control of blood glucose levels with a target of 4,4 to 6 mmol/l using continuous iv infusion of insulin up to intensive care unit discharge. a2=50 mg iv every 6 hours of hydrocortisone (hemisuccinate) for 7 days and strict control of blood glucose levels with a target of 4,4 to 6 mmol/l using continuous iv infusion of insulin up to intensive care unit discharge. control arm b: b1:50 mg iv every 6 hours of hydrocortisone (hemisuccinate), 50µg through the nasogastric tube of 9 alpha fludrocortisone, for 7 days. b2:50 mg iv every 6 hours of hydrocortisone (hemisuccinate)for 7 days. study primary outcome : in-hospital mortality sample size calculation : the expected in-hospital mortality rate in the control group is 50%. to detect an absolute reduction in in-hospital mortality rate of 12.5 %, that is 37.5% in the experimental arm versus 50% in the control arm, and considering risk alpha of 0,05 and a risk beta of 0,20, 254 patients per treatment arms are needed, for a total of 508 patients.

Eligibility criteria:
inclusion criteria: patients admitted in intensive care units for septic shock and meeting all following criteria * proven infection * need for vasopressor to maintain systemic arterial tension above 90 mmhg * multiple organ dysfunction as defined by a sofa score ³ 8. * need for treatment with moderate dose of corticosteroids exclusion criteria: one of the following : * pregnancy * less than 18 years old * moribund (i.e. expected to die on day of intensive care unit admission)

Keywords: septic shock adrenal insufficiency glucose control mineralocorticoids
study of syb p-1501 (fentanyl hci) for treatment of postoperative pain

Conditions: Postoperative Pain

Summary: this is a phase 3 clinical trial to compare the safety and efficacy of syb p-1501 with the syb p-1501 placebo for the management of the first 24 hours of post-operative pain.


Eligibility criteria:
patients who meet all of the inclusion criteria from the day of informed consent to one day before surgery and to whom none of the exclusion criteria is applicable will be eligible to participate in the study. inclusion criteria: 1. expected to require opioid analgesia for management of post-operative pain for at least 24 hours after surgery and require postoperative pain control 2. underwent one of the following surgeries under general anesthesia: * abdominal surgery (e.g., gastrointestinal, gynecological) * orthopedic surgery (e.g., spinal surgery) * thoracic surgery (e.g., respiratory surgery not requiring chest tubes after surgery) 3. asa physical status i, ii or iii 4. age: at least 20 years 5. sex: men or women (negative pregnancy test for women of childbearing potential). 6. inpatient/outpatient status: inpatient 7. received adequate information about the study and gave a written consent to participate in the study by himself/herself exclusion criteria: 1. expected to use continuous intra-operative and post-operative analgesia with local pain control techniques (e.g., spinal/epidural analgesia, nerve block) 2. scheduled for body surface surgery (e.g., burn, breast reconstruction, skin grafting) 3. hypersensitive/allergic to fentanyl, skin adhesive and/or cetylpyridinium chloride 4. expected/scheduled to undergo additional surgical procedure within 36 hours post-operation 5. known or suspected opioid tolerance 6. skin disorder that precludes application of investigational product 7. increased intracranial pressure 8. concomitant asthma, severe respiratory disorder 9. having had convulsive seizure attacks within 5 years 10. patient with medical devices implanted in the body, such as cardiac pacemakers or implantable defibrillators 11. history of opioid, drug and/or alcohol abuse 12. women who are pregnant, might be pregnant, or are breastfeeding 13. using any investigational drug, used any investigational drug within the last 6 months 14. otherwise determined ineligible to participate in the study at the discretion of the principal investigator or sub-investigator